Healthcare

With Japan's aging population and low birthrate, and the rapid advances being made globally in the fields of medical technology and pharmaceuticals, healthcare in all its forms is an ever-growing market in Japan. In recognition of this, Atsumi & Sakai has established a "Healthcare Team" to provide a comprehensive, coordinated and cost-effective legal service across this broad field.

Practice Areas

Atsumi & Sakai’s Healthcare Team has a broad range of legal knowledge and experience across the various fields and industries that comprise healthcare, including:

Pharmaceuticals

Medical equipment & devices

Provision of health and care services

Regulation and compliance

Clinical trials

Research and development

Advertising and sales

Licensing of rights

Each of these has its own set of legal issues and the Healthcare Team comprises Japanese and foreign attorneys with broad knowledge and experience of the healthcare industry, some of whom have worked directly in the industry as in-house lawyers. This enables us to provide clients, foreign and domestic, with appropriate legal advice that meets their specific needs no matter which field of business or, which activity is involved.

Services

Regulatory Advice

As in most countries, the healthcare industry, and in particular the pharmaceuticals industry is highly regulated in Japan, with the laws and regulations being subject to interpretation and guidance from the relevant ministries, etc. Atsumi & Sakai has a proven track record in providing advice on the latest developments in the various regulations and government guidelines, and liaising with the regulatory authorities at all stages from product and service development, to advertising and sales.

Contract negotiation

The members of the Healthcare Team have extensive experience in preparing, reviewing, negotiating and advising on contracts and other documents for healthcare clients, including joint development agreements, license agreements for products, services and rights, sales agreements, agency agreements, and various M&A related documentation.

Industry-specific knowledge and experience

Each industry has its own language and ways of doing business in a specific area of expertise. The Healthcare Team has lawyers with knowledge of different industries or industry categories, which enables us to provide efficient and appropriate legal services using the team members most suitable to the client's needs.

International Transactions

Healthcare in all its forms will probably be one of the most attractive markets for foreign investment into Japan over the medium term; as the only independent full-service Tokyo law firm with non-Japanese partners,Atsumi & Sakai is uniquely placed to provide clear advice and international style documentation through the utilization of teams of foreign and Japanese attorneys with experience on international matters.

Ancillary issues

Healthcare matters, in particular cross-border and domestic acquisitions and joint ventures will often throw up ancillary legal issues, such as:

Intellectual property protection

Data protection

Antitrust

IP and personal injury litigation

Labour law

Immigration

The Atsumi & Sakai Healthcare Team can address such issues, and can call on the resources and experience of the firm’s other practice teams as necessary.

Recent experience of members of the team includes:

Provision of general legal advice for a foreign medical device/equipment manufacturer

Support for the stock listing of a bio-venture company

Provision of legal advice to a drug manufacturer in relation to its use of intellectual property rights

Provision of legal advice to a foreign pharmaceutical company regarding regulation under the Pharmaceutical Affairs Act

Provision of a range of legal advice to a hospital

Provision of legal advice to a client on regulations in the field of medical care and health care in relation to setting up a new business

Legal advice on a cross-border M&A in the field of medical care and health care

Advising a European company on the acquisition of a pharmaceutical distribution business